Bloom Hotel

Visit MARACA International at MedTech Summit

MARACA International presents its services at the MedTech Summit Meeting on 11-15 June in Brussels at Hotel NH Brussels Bloom. When you have questions about the new MDR or IVDR and the impact on your company, contact Dr. Van Hove at www.maracainternational.com and we’ll get you on the right track.
MARACA International bvba is a Belgian consulting company providing service excellence for Regulatory, Quality, Clinical and Medical Affairs assignments at Medical Device, IVD and pharma companies, clinical laboratories, notified bodies and governmental agencies. These services support your product registrations in Europe under the MDD, IVDD, MDR and IVDR regulations. In the USA, our services support your submissions to the FDA. Our services include training, Quality System management, risk management, development of Design Dossiers and Technical files, registration of devices, clinical evaluation reports, scientific validity reports and post-market follow-up plans and reports.

Visit MARACA at EU MD IIS Meeting in Brussels

MARACA International has announced it will be present at the EU MD IIS Meeting in Brussels.
MARACA International is a Belgian consulting company providing service excellence for regulatory, quality, clinical and medical affairs assignments. The company serves medical device, in-vitro diagnostic device (IVD) and pharmaceutical companies, as well as clinical laboratories, notified bodies and governmental agencies.
These services support your product registrations in Europe under the Medical Device Directive (MDD), In-Vitro Diagnostic Device Directives (IVDD), Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) regulations. In the US, MARACA’s services support your submissions to the US Food and Drug Administration (FDA).
MARACA International’s services include training, quality system management, risk management, development of design dossiers and technical files, registration of devices, clinical evaluation reports, scientific validity reports and post-market follow-up plans and reports.
Visit MARACA International at the meeting from 16 May to 17 May at Sheraton Brussels Airport Hotel.

MARACA International Presents at RAPS Workshop on the new IVDR and MDR

MARACA International CEO Dr Luc Van Hove has announced he will be making a presentation regarding the in-vitro diagnostics regulation (IVDR) implementation from an in-vitro diagnostics (IVD) company perspective at the RAPS Workshop on IVDR & MDR.
Taking place from 16 May to 17 May in Brussels, Belgium, attendees will gain an understanding of the general safety and performance requirements (GSPR) changes versus the essential requirements (ER), as well as on the transition strategies for the implementation of the IVDR and the medical device regulation (MDR).
The RAPS Workshop is a key opportunity for visitors to learn the practical applications of the new EU regulatory requirements. Regulatory affairs experts will share valuable insights and unique perspectives on how to address the challenges posed by new regulations.
Sessions will include keynote speakers from the European Commission (EC), updates on the competent authority medical devices (CAMD) roadmap, and both MDR and IVDR changes related to clinical expectations, general safety and performance, technical documentation, labelling and post-market requirements.

MEDTECH MEETUP 2018

Visit MARACA at MEDTECH MEETUP in Brussels 22/03/2018

Visit first our MARACA International booth at the MEDTECH MEETUP in Brussels and get your 25% promo discount code for your onside registration to the meeting. Then come back and ask Dr. Van Hove, our physician, all questions you have on your Medical device or IVD registrations in Europe or in the USA.

MARACA International offers a full suite of regulatory, medical and clinical services that help bring your devices to the market in Europe or the USA.

Get your free consult at the meeting.

MARACA offers training on the MDR and IVDR regulations. We can assess your company status to get into compliance with the MDR or IVDR or with ISO 13485:2016. MARACA can help develop the Technical File or Design Dossier. We can run systematic literature reviews and help you develop your scientific validity report, your clinical validity report or your Clinical evaluation report (CER) or Performance evaluation report (PER). Our board certified physician can approve your CER/PER as medical Evaluator. When the CER identified a need for a clinical investigation. He can develop an executive summary for a clinical study. He can also develop a Post-Market Clinical Follow-up (PMCF) Plan when on-market studies are needed. MARACA can organize your clinical study and develop the study plans and reports.

When adverse events happen, we can handle your risk management. Our physician will assess the patient impact for harm. He will formulate the risk-clinical benefit summary for your device. Where after he’ll make a recommendation on how to mitigate the risks.

When you are looking for service excellence for your regulatory, medical or clinical activities come and talk to us at the MARACA booth.

MARACA International invited to attend the RAPS Netherlands Chapter meeting

Dr. Luc Van Hove from MARACA International has been invited to participate in the RAPS Netherlands Chapter meeting, which can only be attended by special invitation only.
Taking place on 9 February 2018 in Arnhem, MARACA International will exchange ideas on the implementation of the new medical device regulations (MDR) and in-vitro diagnostic medical device regulation (IVDR).
In addition, the implementation acts and guidance will be reviewed. As well as the status of the notified body accreditations and transition will be discussed.
Other items of discussion include the future of MEDDEVs and common specifications. How to develop clinical evaluations for products under the MDR and IVDR.  Finally, the post-market surveillance and risk management requirements will be discussed under the new regulations.
There will be a lot of questions and MARACA International will be the first to understand the best answers.

Amstelveen Companion Diognostics RAPS NL Meeting

Companion Diagnostics IVDR implementation

Luc Van Hove, Founder of MARACA International and Principal Consultant is presenting on Companion Diagnostics IVDR regulation implementation from an IVD Company perspective at the RAPS Netherlands Chapter Meeting, 24 November in Amstelveen, The Netherlands.  Learnings: Understanding the difference between Companion diagnostic devices and Complementary diagnostic devices. The implementation steps of the IVDR for these products. What pathway to follow.

See also e-learning training on Companion Diagnostics.

MARACA International is a consulting company providing service excellence in Regulatory, Clinical and Medical Affairs services to Medical Device, IVD and pharma companies, clinical laboratories and notified bodies.

Medica 2017 exhibition

Medica 2017 Trade Fair

MARACA International participates at the Medica 2017 Trade Fair, 13-16 November, in Dusseldorf, Germany. When you want to learn more about the consulting services of MARACA International or want to meet Dr. Luc Van Hove, its CEO, contact lucvanhove@maracainternational.com or call 32476960153 to set up an appointment.

MARACA International provides consulting excellence for Regulatory, Clinical and Medical Affairs services to Medical Device, IVD and pharma companies, clinical laboratories and notified bodies. The services include setting up quality systems, risk management, organization of clinical studies and product registrations in the EU and the USA.

see Medica 2017 video on spotlight.

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RAPS Regulatory Convergence

MARACA International will be at the RAPS Regulatory Convergence, National Harbor, Washington DC Waterfront, 9-12 September, 2017.

You can meet Dr. Van Hove at the convention by contacting him at maracainternational.com

Pilot for Software

FDA launched pilot for Software as a Medical Device (SaMD) Precertification program

FDA launched on August 1st a new pilot for Software as a Medical Device (SaMD) Precertification program. US software manufacturers and software manufacturers from abroad can apply for participation. FDA intends to select 9 companies to learn from their best practices of software development. Other software companies will be allowed to provide continuous input. FDA and these 9 companies (large, small, traditional, new entrant, best-in-class, low and high risk) will develop Key Performance Indicators (KPIs) to monitor whether a software manufacturer has a culture of quality and of organizational excellence.

This company culture of quality and organizational excellence needs to provide a safe patient experience; deliver the highest product quality; being clinically responsible; being cybersecurity responsible; and being proactive instead of reactive. By January 2018 FDA will report their findings. This new concept should allow faster market authorization for new innovative SaMDs through a new route of software manufacturer precertification. This precertification would result into a streamlined premarket review and a faster commercial distribution and real-world use. The software manufacturer would collect real-world data to further improve their SaMD.

For MARACA International support with your US authorization of your SaMD contact us  for a discussion and proposal.

Brussels Workshop

MARACA International was at the RAPS EU MDR/IVDR Brussels Workshop 4–5 July 2017.

Dr. Van Hove participated in the discussions on the implementation of the new European Medical Device Regulation (MDR) and the new In vitro Diagnostic Device Regulation (IVDR).